The BOOST (Bevacizumab Ovarian Optimal Standard Treatment) Trial
Phase 1
- Conditions
- Epithelial ovarian cancer, fallopian tube carcinoma, primary peritoneal carcinoma, FIGO Stages IIb-IVMedDRA version: 14.1Level: LLTClassification code 10033130Term: Ovarian cancer NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-001015-32-FI
- Lead Sponsor
- Johanna Mäenpää
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 796
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 498
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 298
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare progression-free survival (PFS)<br>(by RECIST v1.1, clinical or symptomatic);Secondary Objective: Objective response rate (ORR) by<br>RECIST v1.1)<br>Overall survival (OS)<br>Quality of life (QoL)<br>o QOL and symptom control will be<br>assessed using EORTC QLQ-C30<br>Safety and tolerability;Primary end point(s): 28% increase in PFS as compared to standard treatment;Timepoint(s) of evaluation of this end point: Every 12 weeks
- Secondary Outcome Measures
Name Time Method